An interventional study of Breakfast in Breakfast and Appetitive Behavior, sponsored by Purdue University. Completed at 1 site in United States. Open to participants aged 15 Years to 21 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-05-02.
Sponsored by Purdue University · Not applicable, Interventional, and Other
75 overweight, habitual 'breakfast-skipping' adolescents will complete the following long-term, randomized controlled trial. Participants will be randomly assigned to the following breakfast treatments: 350 kcal high protein breakfasts containing 30 g protein (primarily from lean beef), 35 g carbohydrates, and 10 g fat; 350 kcal normal protein breakfasts containing 10 g protein, 55 g carbohydrates, and 10 g fat; or will continue to skip breakfast. The following outcomes will be assessed during baseline and 4-month (post-intervention): body weight \& body composition; waist circumference; daily food intake; 24-h free-living glycemic control; and pre and post-prandial satiety. In addition, body weight and free-living breakfast intake (quantity, quality, and type) will also be assessed at 2-month follow-up
The NP and HP groups will be provided with their respective breakfast meals to consume, at home, between 6:00-8:00 am each day over the 4-mo intervention. The energy content of the NP and HP breakfast meals will be standardized to 350 kcal. The energy content of the breakfast meals is \~18% of daily energy intake estimated from the energy expenditure equations specific for adolescents ages 13-16 y. The NP breakfasts will be 11% protein (10 g protein), 63% CHO, and 26% fat, whereas the HP breakfasts will be 34% protein (30 g protein), 40% CHO, and 26% fat. The types of protein incorporated within the NP and HP meals will include a combination of beef (40%), dairy (20%), eggs (20%), and plant-based (20%) proteins. The NP and HP meals will include the same types of breakfasts but will vary in protein and CHO content. An 8-d breakfast rotation will occur throughout the study.
Purdue University is the lead sponsor of 168 studies on the registry; 23 are open to participants now.
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Exclusion Criteria:
The BS group will continue to skip breakfast.
The NP groups will be provided with the respective breakfast meals to consume, at home, between 6:00-8:00 am each day over the 4-mo intervention. The energy content of the breakfast meals will be standardized to 350 kcal. The NP breakfasts will be 11% protein (10 g protein), 63% CHO, and 26% fat
Dietary Supplement: Breakfast
The HP group will be provided with the respective breakfast meals to consume, at home, between 6:00-8:00 am each day over the 4-mo intervention. The energy content of the breakfast meals will be standardized to 350 kcal. The HP breakfasts will be 34% protein (30 g protein), 40% CHO, and 26% fat.
Dietary Supplement: Breakfast
If randomized to a breakfast consuming group, participants will be given breakfasts to consume between 6:00-8:00 am.
Body Weight Change
Body weight will be determined with a standard scale.
Time frame: Baseline and 4 months
Body Composition Change
Whole body total, fat, and fat free mass will be determined with DXA (GE) within the Bone and Body Composition Core of the Clinical Research Center. The DXA uses a linear X-ray fan beam with switched-pulse dual-energy and a multi-element detector array. The whole body scan takes \<1.8 sec with radiation exposure of 0.01mGy. Waist circumference will be measured using a tape measure by one of the trained study staff members.
Time frame: Baseline and 4 months
Energy Intake Change
To assess the participant's total energy content all subjects will complete 3 dietary recalls over a 7-day period. The 3 days of data will be averaged together. Trained staff will contact the participant on 3 separate days (over a 7-day period) and ask questions related to the quantity, type, brand, preparation, and timing of food consumed throughout the previous day. Average energy intake will be assessed using the multi-pass system and NDSR (Nutrition Data System for Research). Change in energy intake(assessed as total energy content in kcal) will be determined.
Time frame: Baseline and 4 months
24-h Free-Living Glycemic Control Change
Free-living, glucose measures will be performed for 6 consecutive days using the Continuous Glucose Monitoring (CGM; Medtronic; Minneapolis, MN) used in our pilot study (1). The participants will report to our facility during the afternoon (on Day 1) for CGM insertion. A small area on the participant's abdomen will be cleaned and the tiny glucose sensor will be inserted just under the skin and held in place with tegaderm tape. The CGM measures glucose every 10sec and records an average glucose value every 5min for up to 144h. Calibration is performed by 4 finger sticks/d with a glucose analyzer.
Time frame: Baseline and 4 months
Sleep Health Change
Sleep health will be measured during 7 consecutive days through accelerometry/actigraphy (Actiwatch, Respironics; Philips, Pittsburgh PA). This device will be worn on the wrist, and the participants will continuously wear it over a 7-day period for measures of sleep quality.
Time frame: Baseline and 4 months
Daily Appetite Change
Questionnaires assessing the appetitive sensations (i.e., hunger, fullness, desire to eat, prospective food consumption), food cravings (sweet, savory-fat, meat), breakfast palatability (i.e., appearance, aroma, flavor, texture, overall liking), and perceived energy (sleepiness, energy, alertness) will be completed every waking hour for 3 days over a 7-day period. The questionnaires contain VAS incorporating a horizontal line rating scale for each response. The questions are worded as "how strong is your feeling of" with anchors of "not all" to "extremely." The questionnaires will be completed on an iPod Touch using an in-house designed application (ScaleKit).
Time frame: Baseline and 4 months
Food Craving Inventory Change
Participants will fill out a Food Craving Inventory (FCI) questionnaire at baseline and 4-month (post-intervention). The FCI is a reliable and valid self-report measure of general and specific food cravings including cravings for high fat foods, carbohydrates/starches, sweets, and fast food (2). The FCI defines a craving as an intense desire to consume a particular food (or food type) that is difficult to resist. Further, this questionnaire prompts the participant to report how often (never, rarely, sometimes, often, always/almost every hour) he/she experienced a craving for the food throughout the day today.
Time frame: Baseline and 4 months
Body Weight (2-months post-intervention termination) Change
Body weight will be determined with a standard scale.
Time frame: 5 months and 6 months
Breakfast Intake (2-months post-intervention termination) Change
To assess the participant's energy content at breakfast, all subjects will complete 3 dietary recalls over a 7-day period and an average will of the 3 recalls will occur. Trained staff will contact the participant on 3 separate days (over a 7-day period) and ask questions related to the quantity, type, brand, preparation, and timing of food consumed throughout the previous breakfast meal. Breakfast energy content will be assessed using the multi-pass system and NDSR (Nutrition Data System for Research).
Time frame: Average of 3 days at 6 months
Plan to share: No
This study is completed, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.
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